Drug Approval | November 14, 2022
Stelis receives recommendation from EMA granting market authorization for Kauliv
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.
PIKA COVID-19 vaccine is currently in Phase 3, multi-country, multi-center clinical trial conducted at Southeast Asian and Middle East countries.
The company has successfully developed Methyl salicylate using Flow Chemistry and successfully erected a Flow reactor at Jhagadia plant and expects to start production from Q3 FY23
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.
The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue
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